A Randomized, Double-Blind, Placebo-Controlled Trial of Methyl Aminolevulinate + Aktilite in Patients With Facial Photodamage
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Efficacy in facial global photodamage
研究概览
简要总结
The aim of the study is to determine the efficacy of MAL + Aktilite versus placebo + Aktilite in facial photodamage in a randomized double blind trial.
详细描述
It has been demonstrated that photodamage leads to wrinkles, mottled pigmentation, lentigines, telangiectasias, and textural changes, but more importantly, it can also lead to pre-cancerous conditions with the development of actinic keratosis (AK). The majority of photorejuvenation or photodamaged published studies have used 5-Amino-Levulinic acid (5-ALA) as a photosensitizer, and either a blue light or an Intense Pulsed Light source with a 70%-95% global facial skin improvement. The molecular mechanism of such improvement is unknown, but activation of a non-specific immune response in addition to increased fibrosis and new collagen formation, have both been suggested.
Methyl Aminolevulinate ( MAL) is another marketed photosensitizer mainly utilized in Europe. Lipophilicity, higher penetration depth and tumor selectivity has been advocated for MAL compared to 5-ALA. However, its effect in photodamaged skin has not been well documented.
The aim of the study is to determine the efficacy of MAL + Aktilite (PDT) in facial photodamage.
Study Type: Interventional
Study Design: Randomized, double-Blind, placebo-controlled trial. Official Title: A randomized, double-Blind, placebo-controlled trial of Methyl Aminolevulinate + Aktilite in patients with facial photodamage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects older than 35 years of age and less than 75 years of age
- •Subjects with a photodamage grade of 2 or 3 according to a modified Dover´s Global photodamage scale
- •Subjects willing to participate according to protocol requirements.
- •Patients with signed Informed Consent
- •Patients with no exclusion criteria
排除标准
- •Pregnant or nursing females.
- •Subjects with suspected porphyria, Systemic or cutaneous erythematosus lupus, or any other photosensitizing disorder or drug induced photosensitization.
- •Any active infectious skin disorder ( Herpes simplex, molluscum contagiosum, facial warts )
- •Subjects with less than 6 months of previous rejuvenation interfering treatments
- •Subjects requiring concurrent treatment that would interfere with study objectives and/or assessments.
研究组 & 干预措施
A
干预措施: Methyl Aminolevulinate (Drug)
B
干预措施: Moisturizer (Other)
结局指标
主要结局
Efficacy in facial global photodamage
时间窗: 8 months
次要结局
- Facial fine lines, mottled pigmentation, tactile roughness, sallowness, erythema, telangiectasia(12 months)
- Histological effect of MAL+PDT in fibrosis and new collagen formation(12 months)
- Safety and tolerance(12 months)